Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
NCT ID: NCT01598259
Last Updated: 2016-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2014-05-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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melatonin
Subjects will receive melatonin
Melatonin
po 1 hour before bedtime
placebo
placebo
po, 1 hour before bed
Interventions
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Melatonin
po 1 hour before bedtime
placebo
po, 1 hour before bed
Eligibility Criteria
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Inclusion Criteria
* Scheduled for an elective surgical procedure
* 5 - 22 years of age, inclusive
Exclusion Criteria
* History of head injury within the last year
* Pre-existing seizure disorder
* Pre-existing neurological disorder
* Pre-existing blindness
* Known hypersensitivity to melatonin
* Anticoagulant use or aspirin therapy
* Antihypertensive medication use
* Diabetes mellitus or other endocrine disorders
* Autoimmune disorders
* Schizophrenia
* Inability to access internet
* Intellectual disability or inability to follow directions
5 Years
22 Years
ALL
No
Sponsors
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Shriners Hospitals for Children
OTHER
Responsible Party
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Michele Gottschlich
Research Scientist
Locations
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Shriners Hospital for Children
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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2012-1613
Identifier Type: -
Identifier Source: org_study_id
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